Care One 072.002/072an

Care One 072.002/072an
SPL v3
SPL
SPL Set ID 79b4969c-9cc8-4b51-8bf8-8dfcc412fb41
Route
ORAL
Published
Effective Date 2025-04-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Eucalyptol (0.92 mg) Menthol (0.42 mg) Salicylic Acid (0.6 mg) Thymol (0.64 mg)
Inactive Ingredients
Alcohol Sorbitol Poloxamer 407 Benzoic Acid Saccharin Sodium Sodium Citrate D&c Yellow No. 10 Fd&c Green No. 3 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-04-18

Description

Eucalyptol 0.092% Menthol 0.042% Methyl sailcylate 0.060% Thymol 0.064%

Purpose

Antigingivitis, Antiplaque


Medication Information

Purpose

Antigingivitis, Antiplaque

Description

Eucalyptol 0.092% Menthol 0.042% Methyl sailcylate 0.060% Thymol 0.064%

Use

helps control plaque that leads to gingivitis

Warnings

For this product

Directions

adults and children under 12 years if age and older - vigorously swish 20 ml (2/3 FL OZ or 4 teaspoonfuls) between teeth for 30 seconds then spit out; do not swallow

children under 12 years of age - consult a dentist or doctor

  • this rinse is not intended to replace brushing or flossing
Disclaimer

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of FreshBurst ® Listerine Antiseptic Mouthwash.

Do Not Use If

you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth.  See your dentist immediately.  These may be signs of periodontitis, a serious form of gum disease.

Adverse Reaction

DISTRIBUTED BY FOODHOLD, U.S.A., LLC

LANDOVER, MD 20785

1-844-846-9949

©2018 S&S Brands, LLC

Quality Guaranteed or Your Money Back.

DSP-TN-15000

DSP-MO-34

SDS-TN-15012

Other Information

cold weather may cloud this product.  Its antiseptic propeties are not affected.  Store at room temperature (59° -77° F).

Active Ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl sailcylate 0.060%

Thymol 0.064%

Inactive Ingredients

water, alcohol (21.6 %), sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate, D&C yellow no. 10, FD&C green no.3

Principal Display Panel

careone ®

Compare to FreshBurst ® Listerine ® Antiseptic Mouthwash*

ANTISEPTIC MOUTH RINSE

ANTIGINGIVITIS/ANTIPLAQUE

KILLS GERMS THAT CAUSE BAD BREATH, PLAQUE AND THE GUM DISEASE GINGIVITIS

SPRING MINT ®FLAVOR

Sealed With Printed Neckband For Your Protection

16.9 FL OZ (500 mL) 

Stop Use and Ask A Dentist If

gingivitis, bleeding, or rednss persists for more than 2 weeks

Keep Out of Reach of Children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Use

helps control plaque that leads to gingivitis

Purpose

Antigingivitis, Antiplaque

Warnings

For this product

Directions

adults and children under 12 years if age and older - vigorously swish 20 ml (2/3 FL OZ or 4 teaspoonfuls) between teeth for 30 seconds then spit out; do not swallow

children under 12 years of age - consult a dentist or doctor

  • this rinse is not intended to replace brushing or flossing
Disclaimer

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of FreshBurst ® Listerine Antiseptic Mouthwash.

Do Not Use If (Do not use if)

you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth.  See your dentist immediately.  These may be signs of periodontitis, a serious form of gum disease.

Adverse Reaction (Adverse reaction)

DISTRIBUTED BY FOODHOLD, U.S.A., LLC

LANDOVER, MD 20785

1-844-846-9949

©2018 S&S Brands, LLC

Quality Guaranteed or Your Money Back.

DSP-TN-15000

DSP-MO-34

SDS-TN-15012

Other Information (Other information)

cold weather may cloud this product.  Its antiseptic propeties are not affected.  Store at room temperature (59° -77° F).

Active Ingredients (Active ingredients)

Eucalyptol 0.092%

Menthol 0.042%

Methyl sailcylate 0.060%

Thymol 0.064%

Inactive Ingredients (Inactive ingredients)

water, alcohol (21.6 %), sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate, D&C yellow no. 10, FD&C green no.3

Principal Display Panel (Principal display panel)

careone ®

Compare to FreshBurst ® Listerine ® Antiseptic Mouthwash*

ANTISEPTIC MOUTH RINSE

ANTIGINGIVITIS/ANTIPLAQUE

KILLS GERMS THAT CAUSE BAD BREATH, PLAQUE AND THE GUM DISEASE GINGIVITIS

SPRING MINT ®FLAVOR

Sealed With Printed Neckband For Your Protection

16.9 FL OZ (500 mL) 

Stop Use and Ask A Dentist If (Stop use and ask a dentist if)

gingivitis, bleeding, or rednss persists for more than 2 weeks

Keep Out of Reach of Children. (Keep out of reach of children.)

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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